|Publication number||US7125424 B2|
|Application number||US 10/261,082|
|Publication date||Oct 24, 2006|
|Filing date||Sep 27, 2002|
|Priority date||Sep 28, 2001|
|Also published as||CA2461407A1, EP1429692A2, US20030093153, US20070010886, WO2003026522A2, WO2003026522A3|
|Publication number||10261082, 261082, US 7125424 B2, US 7125424B2, US-B2-7125424, US7125424 B2, US7125424B2|
|Inventors||Christopher M. Banick, Jack A. Dant, David A. Hanson, Rodney L. Houfburg|
|Original Assignee||Zimmer Spine, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (31), Referenced by (16), Classifications (42), Legal Events (6)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims priority to U.S. Provisional application 60/325,804, filed Sep. 28, 2001.
The present invention relates generally to skeletal implants. More particularly, the present invention relates to implants for stabilizing intervertebral joints.
Chronic back problems cause pain and disability for a large segment of the population. In many cases, chronic back problems are caused by intervertebral disc disease. When an intervertebral disc is diseased, the vertebrae between which the disc is positioned may be inadequately supported, resulting in persistent pain. Stabilization and/or arthrodesis of the intervertebral joint can reduce the pain and debilitating effects associated with disc disease.
Spinal stabilization systems and procedures have been developed to stabilize diseased intervertebral joints and, in some cases, to fuse the vertebrae that are adjacent the diseased joint space. Most fusion techniques include removing some or all of the disc material from the affected joint, and stabilizing the joint by inserting an implant (e.g., a bone graft or other material to facilitate fusion of the vertebrae) in the cleaned intervertebral space.
Spinal implants can be inserted into the intervertebral space through an anterior approach, a posterior approach, or postero-lateral approach. The anterior approach involves a surgeon seeking access to the spine through the front (i.e., abdominal area) of the patient. The posterior approach involves a surgeon seeking access to the spine through the back of the patient. The postero-lateral approach is similar to the posterior approach with access coming more from either or both sides of the patient. A variety of different anterior, posterior and postero-lateral techniques are known.
It is often an advantage to use the posterior approach because such an approach typically involves a smaller and less intrusive opening than those required by anterior approach techniques. Because a posterior approach involves a smaller opening, two or more implants are often used in this approach as compared to using a single larger implant. For example, in one technique, adjacent vertebral bodies are stabilized by implanting separate implants between the vertebral bodies on opposite sides of a sagittal plane passing through the midline of the vertebral bodies. When using multiple implants to support adjacent vertebrae, it is desirable for the implants to have similar or identical mechanical properties so that uniform support is provided on both sides of the sagittal plane. In some instances, it also is desirable for the implants to have similar or identical biologic properties (e.g., to reduce the risk of tissue rejection and to enhance the uniformity of creeping substitution).
One aspect of the present invention relates to skeletal implants and skeletal implant kits adapted to ensure that multiple implants used to support opposing vertebrae have been derived from the same source.
A variety of other aspects of the invention are set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practicing the invention. The aspects of the invention relate to individual features, as well as combinations of features. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
The present invention is directed to skeletal implants, skeletal implant kits and methods for placing implants between bones desired to be fused. It is preferred for the implants to be used for vertebral/spinal applications such as fusing cervical, thoracic and/or lumbar intervertebral joints. In the case of fusing an intervertebral joint, implants in accordance with the principles of the present invention can be implanted using an anterior, posterior or postero-lateral approach to the patient's vertebrae.
As used herein, an “implant” includes any implant suitable for facilitating fusion between adjacent bones and includes implants prepared from known implant materials including, non-bone material such as titanium, stainless steel, porous titanium, bio-glass, calcium phosphate, ceramic, carbon fiber-based polymers, biodegradable and polymers. However, it is preferred for implants in accordance with the principles of the present invention to be derived from natural bone tissue (e.g., allograft and xenograft bone). It is most preferred for implants in accordance with the principles of the present invention to be derived from natural bone such as from a cadaveric allograft bone source. For example, the implants can be derived by cross-sectioning cortical rings from cadaveric allograft bones such as femur, tibia or fibia bones. Alternatively, the implants can be formed/molded from ground, sintered or composite bone material. Bone tissue cut from a human femur bone is particularly suited for use in practicing the principles of the present invention. Xenograft bones (e.g., from a bovine source) also can be used.
The term “allograft” will be understood to mean a bone implant from a donor transplanted to a genetically dissimilar recipient of the same species. The term “xenograft” will be understood to mean a bone implant from a donor transplanted to a recipient of a different species.
As shown in
Referring again to
Preferably, the controlled break location is configured to allow the first and second pieces 22, 24 of the implant member 20 to be manually broken or “snapped” apart without requiring the use of a tool. The controlled break structure ensures that the implant 20 will break at a predetermined location (e.g., at the axis of symmetry 38 for the embodiment of
Although the embodiment of
Referring again to
The grooves 44 of the implant 20 function to resist migration of the implant upon implantation between opposing bone surfaces. Other structures such as teeth, serrations, cross-cut serrations, notches, bumps, ridges, projections or other surface treatments could also be used.
While the implant 20 can have a constant thickness, it is preferred for the implant 20 to be slightly tapered. In one embodiment, the spinal implant 20 can be tapered about 3 degrees such that a front end 48 of the implant 20 has a thickness Tf that is greater than a thickness Tr located at a rear end 50 of the implant 20. The thicknesses Tf and Tr are labeled in
While other materials could be used, the spinal implant 20 is preferably derived from an allograft bone. In one embodiment, the implant 20 is a transverse cross-section from the femur of a cadaver, and includes a cortical ring. After the ring has been cross-sectioned, relatively soft bone tissue and marrow from the interior of the ring is preferably removed. Next, a portion of the outer cortical ring is removed (e.g., by a technique such as mechanically cutting with a blade or abrasion tool, laser cutting, etching, etc.) to provide the open end of the pocket 26 of the “C” shaped implant 20 (see
The configuration of the implant of
To implant the spinal implant 20, a diseased disc between two adjacent vertebrae 72, 74 is preferably removed using a conventional discectomy procedure (i.e., partial or complete discectomy). Opposing end plates 72′ and 74′ of the vertebrae 72, 74 are then preferably prepared to provide relatively flat contact surfaces. The end plates 72′, 74′ are then conditioned (e.g., with a rasp) to provide a more uniform and osteoconductive/osteoinductive site for the implant 20. After the implant site has been prepared, the sterile package of the kit 60 is opened, allowing the surgeon to access the implant 20. Preferably, the implant 20 is then manually “snapped” or broken into two pieces. One of the pieces 22 is then placed on the insertion tool 52. With the insertion tool, the surgeon inserts the first piece 22 into the cleared intervertebral space between the vertebrae 72, 74. Preferably, the first piece 22 is inserted using a posterior approach. As the first piece 22 is inserted, an insertion force is transferred through the insertion tool 52 to the insertion force surface 40 of the first implant piece 22. As shown in
It will be appreciated that the kit 60′ can be used in essentially the same manner as the kit 60, except the kit 60′ does not require the surgeon to manually break the spinal implant 20 into the separate first and second pieces 22, 24. In both embodiments, the surgeon can be assured that both the first and second pieces 22, 24 of the spinal implant 20 were derived from the same donor source.
With regard to the foregoing description, it is to be understood that changes may be made in detail without departing from the scope of the present invention. It is intended that the specification and depicted aspects of the invention may be considered exemplary, only, with a true scope and spirit of the invention being indicated by the broad meaning of the following claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4416629 *||Jul 6, 1982||Nov 22, 1983||Mozsary Peter G||Osseointerfaced implanted artificial tooth|
|US4904261||Aug 4, 1988||Feb 27, 1990||A. W. Showell (Surgicraft) Limited||Spinal implants|
|US5015817||Dec 21, 1989||May 14, 1991||Johnson & Johnson||Method for producing a hollow shaft endoprosthesis|
|US5250048 *||Jan 27, 1992||Oct 5, 1993||Ferdinand Gundolf||Stabilizing element for osteosynthesis of bone fragments, especially for the fixation of bone fractures|
|US5298254||Dec 17, 1991||Mar 29, 1994||Osteotech, Inc.||Shaped, swollen demineralized bone and its use in bone repair|
|US5716415 *||Mar 8, 1996||Feb 10, 1998||Acromed Corporation||Spinal implant|
|US5728159||Jan 2, 1997||Mar 17, 1998||Musculoskeletal Transplant Foundation||Serrated bone graft|
|US6033438||Jun 3, 1997||Mar 7, 2000||Sdgi Holdings, Inc.||Open intervertebral spacer|
|US6102912 *||May 28, 1998||Aug 15, 2000||Sofamor S.N.C.||Vertebral rod of constant section for spinal osteosynthesis instrumentations|
|US6143033||Dec 23, 1998||Nov 7, 2000||Synthes (Usa)||Allogenic intervertebral implant|
|US6174311||Oct 28, 1998||Jan 16, 2001||Sdgi Holdings, Inc.||Interbody fusion grafts and instrumentation|
|US6387130 *||Apr 14, 2000||May 14, 2002||Nuvasive, Inc.||Segmented linked intervertebral implant systems|
|US6468311||Jan 22, 2001||Oct 22, 2002||Sdgi Holdings, Inc.||Modular interbody fusion implant|
|US6475218 *||Jul 2, 2001||Nov 5, 2002||Sofamor, S.N.C.||Spinal implant for an osteosynthesis device|
|US6613090 *||Jul 27, 2001||Sep 2, 2003||Aesculap Ag & Co. Kg||Intervertebral implant|
|US20010031254||Feb 12, 2001||Oct 18, 2001||Bianchi John R.||Assembled implant|
|US20020026244 *||Aug 30, 2001||Feb 28, 2002||Trieu Hai H.||Intervertebral disc nucleus implants and methods|
|US20020106393||Aug 27, 2001||Aug 8, 2002||Bianchi John R.||Assembled implant, including mixed-composition segment|
|US20030093153||Sep 27, 2002||May 15, 2003||Banick Christopher M.||Skeletal stabilization implant|
|US20030149438 *||Dec 17, 2002||Aug 7, 2003||Howmedica Osteonics Corp.||Insertion instrument|
|DE20017962U1||Oct 20, 2000||Jan 4, 2001||Aesculap Ag & Co Kg||Wirbelersatzk÷rper|
|EP0366945A1||Sep 30, 1989||May 9, 1990||Intraplant AG||Femoral prosthesis with a set of fins|
|WO1994005235A1||Sep 4, 1992||Mar 17, 1994||Brantigan John W||Surgical prosthetic implant for vertebrae|
|WO1998017209A2||Oct 21, 1997||Apr 30, 1998||Sdgi Holdings, Inc.||Spinal spacer|
|WO1999009914A1||Aug 27, 1998||Mar 4, 1999||University Of Florida Tissue Bank, Inc.||Cortical bone cervical smith-robinson fusion implant|
|WO2000024327A2||Oct 27, 1999||May 4, 2000||Sdgi Holdings, Inc.||Interbody fusion grafts and instrumentation|
|WO2000040179A1||Jan 5, 2000||Jul 13, 2000||Sdgi Holdings, Inc.||Flexible implant using partially demineralized bone|
|WO2000041654A2||Jan 11, 2000||Jul 20, 2000||Sdgi Holdings, Inc.||Truncated open intervertebral spacers|
|WO2000062719A1||Apr 14, 2000||Oct 26, 2000||Nuvasive, Inc.||Segmented linked intervertebral implant systems|
|WO2000074608A1||Jun 8, 2000||Dec 14, 2000||Osteotech, Inc.||Ramp-shaped intervertebral implant|
|WO2001070137A2||Mar 22, 2001||Sep 27, 2001||Synthes (U.S.A)||Multipiece implants formed of bone material|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8235978 *||Jan 14, 2008||Aug 7, 2012||Valens Associated Inc.||Thermal capsulotomy tool and system|
|US8273127||Jun 6, 2007||Sep 25, 2012||Spinesmith Partners, L.P.||Interbody fusion device and associated methods|
|US8308805||Jan 20, 2012||Nov 13, 2012||Pinnacle Spine Group, Llc||Methods of delivering an implant to an intervertebral space|
|US8343224||Mar 16, 2011||Jan 1, 2013||Pinnacle Spine Group, Llc||Intervertebral implants and graft delivery systems and methods|
|US8657813||Mar 22, 2011||Feb 25, 2014||Valens Associated Inc.||Circular thermal capsulotomy tool and system|
|US8795373||Jan 23, 2008||Aug 5, 2014||Spinesmith Partners, L.P.||Interbody fusion device, integral retention device, and associated methods|
|US8828082||Jul 9, 2010||Sep 9, 2014||R Tree Innovations, Llc||Inter-body implant|
|US8845733||Jun 17, 2011||Sep 30, 2014||DePuy Synthes Products, LLC||Lateral spondylolisthesis reduction cage|
|US9216096||Apr 23, 2015||Dec 22, 2015||Pinnacle Spine Group, Llc||Intervertebral implants and related tools|
|US9226764||Mar 6, 2012||Jan 5, 2016||DePuy Synthes Products, Inc.||Conformable soft tissue removal instruments|
|US9282979||Jun 17, 2011||Mar 15, 2016||DePuy Synthes Products, Inc.||Instruments and methods for non-parallel disc space preparation|
|US9380932||Nov 1, 2012||Jul 5, 2016||Pinnacle Spine Group, Llc||Retractor devices for minimally invasive access to the spine|
|US20080188940 *||Jun 25, 2007||Aug 7, 2008||Zimmer Spine, Inc.||Spinal Implant|
|US20090105830 *||Jan 23, 2008||Apr 23, 2009||Jones Robert J||Interbody fusion device, integral retention device, and associated methods|
|US20090216225 *||Jan 14, 2008||Aug 27, 2009||Joshua Ben-Nun||Thermal capsulotomy tool and system|
|US20110213359 *||Mar 22, 2011||Sep 1, 2011||Joshua Ben-Nun||Circular thermal capsulotomy tool and system|
|U.S. Classification||623/17.11, 623/17.16|
|International Classification||A61F2/46, A61B19/02, A61F2/28, A61F2/30, A61B19/00, A61F2/00, A61F2/44|
|Cooperative Classification||A61F2002/30131, A61F2/4611, A61F2002/4627, A61F2002/3082, A61F2250/0036, A61F2250/0085, A61F2002/30879, A61F2002/448, A61F2002/3071, A61F2002/30168, A61F2230/0019, A61F2002/30153, A61F2002/30925, A61F2002/30785, A61F2002/30828, A61F2/3094, A61F2/0095, A61F2230/0013, A61F2002/30324, A61F2/4455, A61F2002/2825, A61F2002/30975, A61F2002/2839, A61F2002/3097, A61F2230/0043, A61F2/442, A61F2002/30892, A61F2002/4649, A61F2002/30561, A61B2050/314, A61B90/90|
|European Classification||A61F2/46B7, A61F2/44F|
|Jan 21, 2003||AS||Assignment|
Owner name: SULZER SPINE-TECH, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BANICK, CHRISTOPHER M.;DANT, JACK A.;HANSON, DAVID A.;AND OTHERS;REEL/FRAME:013675/0524;SIGNING DATES FROM 20021104 TO 20021221
|Jul 30, 2004||AS||Assignment|
Owner name: ZIMMER SPINE, INC., TEXAS
Free format text: CHANGE OF NAME;ASSIGNOR:CENTERPULSE SPINE-TECH INC.;REEL/FRAME:015642/0498
Effective date: 20040429
|Sep 18, 2006||AS||Assignment|
Owner name: CENTERPULSE SPINE-TECH INC., MINNESOTA
Free format text: CHANGE OF NAME;ASSIGNOR:SULZER SPINE-TECH INC.;REEL/FRAME:018267/0825
Effective date: 20020930
|Mar 13, 2007||CC||Certificate of correction|
|Mar 23, 2010||FPAY||Fee payment|
Year of fee payment: 4
|Mar 26, 2014||FPAY||Fee payment|
Year of fee payment: 8